JP3019393U - Aseptic sampling device - Google Patents

Abstract

(57) [Summary] [Objective] To provide an aseptic sample collecting instrument that enables simple aseptic sample collection without impairing the integrity of aseptic operation. [Structure] A bottomed plastic tube 2 in which the inside is endotoxin-free and in which the inside is in a reduced pressure state; An elastomer stopper 3 arranged on the opening side; and the elastomer stopper 3
An aseptic sampling device 1 comprising a sealing material 4 covering at least a part of the upper part.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to an aseptic collection instrument that is particularly preferably used for aseptic collection of biological samples such as blood, and more specifically, endotoxin, which is a constituent of Gram-negative bacteria, does not actually exist therein. Aseptic collection equipment (endotoxin-free).

[0002]

[Prior art]

 Endotoxin is a component of Gram-negative bacteria (endotoxin), and its detection and quantification is useful for diagnosing sepsis. When this endotoxin is measured, the measured value easily rises due to contamination of samples (specimens) with various bacteria. Therefore, the samples for testing (plasma, serum, etc.) are separated and stored from the sampling of samples (blood collection, etc.). Aseptic operation is required. Conventionally, as a device (or collection container) for collecting a sample (blood etc.) for detecting this endotoxin, a glass bottomed tube (test tube), which has been dry heat sterilized (heated at 180 ° C for about 50 minutes), is used. It has been used.

However, a glass tube has a very high risk of breakage during transportation, and this tendency of breakage becomes remarkable especially when frozen and transported. Such breakage of the glass tube is a factor that significantly impedes the efficiency of clinical examination.

In order to prevent such a damage accident, conventionally, a glass tube containing a sample (specimen) is covered with a paraffin film (trade name: Parafilm; manufactured by American National CAN). ), Etc., were used to "roll the tube and lid" and transport them. However, even in such a case, the glass tube is extremely easily broken (cracked) by freezing itself, and it is complicated and time-consuming to remove the paraffin film at an inspection facility. There was a possibility that the sample itself would be damaged by the film removal work.

The inventors of the present invention have previously proposed an aseptic sample collecting device capable of easily performing aseptic sampling of a sample while preventing damage due to transportation (JP-A-6-34498).

Referring to the schematic diagram of FIG. 12, when this sampling device is used, a heparin solution (for example, heparin sodium injection for Japanese Pharmacopoeia, 1000 units / mL) is preliminarily stored in a syringe 20. After sucking the inside so as to wet it (about 30 μL), about 3 mL of blood 21 is collected using the syringe 20. The collected blood is transferred to the first sterilization test tube as shown in FIG. 12 (a) using the syringe 20 with the injection needle removed, and then as shown in FIG. 12 (b), the aluminum cap 23 is used. After the boundary between the sterilization test tube 22 and the sterilization test tube 22 is wrapped and fixed with a paraffin film 24, the precipitate 21a and the supernatant 21b are separated by cooling and centrifugation (for example, 4 ° C., 2500 rpm, 10 minutes).

Further, as shown in FIG. 12 (c), a sterile dropper 25 is used to transfer the supernatant 21 b obtained above to a second sterilization test tube (made of plastic tube) 26, and immediately, an aluminum cap 27. Cover with. The boundary between the aluminum cap 27 and the second sterilization test tube 26 is wrapped and fixed with a paraffin film (not shown) in the same manner as above, and then frozen if necessary.

[0008]

[Problems to be solved by the device]

 However, in response to the recent increase in the number of samples (specimens) to be tested and the demand for cost reduction, even in the above-mentioned aseptic sampling operation, there is a strong demand for easier or simpler operation. Has been done.

An object of the present invention is to provide an aseptic sampling device that solves the above-mentioned problems in the prior art.

[0010] Another object of the present invention is to provide an aseptic sample collecting instrument that enables simple aseptic sample collection without impairing the integrity of aseptic operation.

[0011]

[Means for Solving the Problems]

 As a result of diligent research, the present inventor found that not only was the plastic tube inside a plastic tube decompressed, and an elastomer stopper was attached to the plastic tube, but the top of the elastomer stopper (plastic It has been found that arranging a sealant covering at least a part of the surface on the side opposite to the tube contact side) is extremely effective for achieving the above-mentioned purpose.

The aseptic sampling device of the present invention is based on the above findings, and more specifically, the inside thereof is aseptic to the extent that endotoxin is substantially absent, and a biological sample can be collected. A bottomed plastic tube whose inside is depressurized to some extent, and an elastomeric plug which is arranged on the opening side of the tube so as to substantially maintain the inside of the plastic tube in a depressurized state. And a sealing material adhered to the elastomer stopper so as to cover at least a part of the surface of the elastomer stopper opposite to the plastic tube contacting side.

According to the present invention, further, the inside is aseptic to the extent that substantially no endotoxin is present, and the inside is depressurized to the extent that a biological sample can be collected. A plastic tube, an elastomer stopper arranged on the opening side of the tube so as to substantially maintain a reduced pressure state inside the plastic tube, and a plastic tube contacting side of the elastomer stopper. Cap member disposed on the elastomer stopper so as to cover the side surface thereof, and a seal adhered to the cap member so as to cover at least a part of a surface of the cap member opposite to the elastomer stopper contact side. An aseptic sampling device is provided.

[0014]

[Action]

 When the aseptic sampling device of the present invention having the above-mentioned configuration is used, when the sampling device is stored or transported, the sealing material disposed on the upper part of the elastomer stopper (further, in the embodiment of the present invention having a cap member) The seal material and / or the cap material) effectively prevent contamination by falling bacteria in the air. On the other hand, aseptic collection of the sample is simplified by removing at least a part of the sealing material immediately before using the sample collection instrument and then collecting the sample by utilizing the reduced pressure in the plastic tube. .

[0015]

【Example】

 Hereinafter, the present invention will be described in detail with reference to the drawings as necessary.

With reference to FIG. 1, which is a schematic cross-sectional view showing one embodiment of the aseptic collection device of the present invention, the collection device 1 of the present invention has a sterile interior to the extent that endotoxin is substantially absent. A bottomed plastic tube (test tube) 2 which is in a decompressed state so that a biological sample can be collected; and a decompressed state inside the plastic tube 2 is substantially An elastomer plug 3 arranged on the opening side of the tube so as to hold the same; and at least the surface of the elastomer plug 3 opposite to the contact side with the plastic tube 2 (the upper surface of the plug 3 in FIG. 1). The seal member 4 is arranged so as to cover a part thereof.

The bottomed (having a bottom) tube 2 is made of a plastic such as polyethylene terephthalate (PET). The inside of the plastic tube 2 is in an endotoxin-free state (that is, the endotoxin is substantially absent inside the tube 2).

(Endotoxin Free) In the present invention, the confirmation of “endotoxin free” can be performed, for example, as follows.

20 containers are randomly selected from the containers to be measured (for example, about 50 containers), and 1.0 mL of endotoxin-free distilled water is dispensed into each container and shaken / mixed well (about 15 Seconds). Using this as a blank solution (test sample), the amount of endotoxin in the above distilled water is measured as follows.

Note that such measurement can be performed using a commercially available reagent for measuring endotoxin (for example, Endotoxin Test-D manufactured by Seikagaku Corporation).

In a reaction tube for measurement kept in an ice-water bath, a horseshoe crab blood cell extract component (lysate), a synthetic substrate (Boc-Leu-Gly-Arg-p-nitroaniline), and 100 μL of a buffer solution were placed. Then, 100 μL of the above blank solution is immediately added, and the mixture is shaken in a test tube mixer for 1 to 2 seconds to mix. After mixing, the reaction tube is transferred to a constant temperature water bath (37 ° C.), heated for 30 minutes, transferred to an ice-water bath, and immediately added 500 μL of sodium nitrite solution and stirred well (stop reaction).

Then, the reaction tube was taken out from the ice-water bath, and 500 μL of ammonium sulfamate solution was added and stirred, and further 500 μL of N- (1-naphthyl) ethylenediamine dihydrochloric acid solution was added and stirred (endotoxin was added to the sample. If present, it is colored red here). The mixture is vigorously stirred again, and the absorbance at 545 nm is measured using water as a control.

Determined using a standard sample solution (eg, concentrations 0, 10, 30, and 40 pg / mL) prepared from a standard sample (eg, endotoxin, E. coli 0111: B4) and endotoxin-free distilled water Determine the amount of endotoxin in the blank solution based on the calibration curve of absorbance-endotoxin concentration.

In the present invention, the endotoxin amount (average value) in the blank solution thus obtained is 0.5 pg / mL or less (further 0.2 pg / mL or less, particularly 0.1 pg / mL or less). (In general, the detection limit of endotoxin is 0.5 pg / mL).

(Plastic Tube) In the present invention, the method for obtaining the endotoxin-free plastic tube 2 is not particularly limited, but, for example, a plastic tube may be prepared by using materials, conditions, etc. that are in an endotoxin-free state. An endotoxin-free plastic tube 2 can be obtained by producing the tube 2 or by decomposing endotoxin using radiation after producing the plastic tube 2.

The material of the plastic forming the tube 2 has such transparency that the presence or absence of the sample in the tube can be visually confirmed (that is, some coloring (for example, yellowing) is allowed). There is no particular limitation as long as it has the strength to withstand transportation after sampling. More specifically, for example, one or two of polyolefin resin (polyethylene (PE), polypropylene (PP), etc.), acrylic resin, styrene resin, polyester resin (polyethylene terephthalate (PET), etc.), polyamide resin. Combinations of the above (eg, laminates or laminates) can be used. It is preferable to use PE or PET (particularly PET) from the viewpoint of transparency after radiation sterilization with γ-rays and the like, and strength from the viewpoint of freezing.

The wall thickness of the tube 2 is preferably about 0.5 to 3 mm or more, and more preferably about 1 to 2 mm from the viewpoint of strength and the like. Further, the diameter of the tube 1 is preferably 0.5 cm or more, more preferably about 1 to 2 cm from the viewpoint of easy handling, and the length is about 3 to 15 cm, further about 5 to 12 cm. preferable.

(Elastomer Plug) The elastomer plug 3 arranged on the opening side of the tube 2 is made of an elastomer such as butyl rubber. From the viewpoint of preventing contamination of the contents of the tube 2, the elastomer is preferably made of a high-quality elastomer for medical use.

From the viewpoint of easy attachment and detachment of the elastomer plug 3 to the tube 2, it is preferable that the upper surface and / or the lower surface of the elastomer plug 3 be provided with recesses 3a and 3b. Further, as shown in FIG. 1, the side surface 3c of the elastomer stopper 3 is tapered so that the radius of the stopper 3 becomes smaller toward the upper side. Is preferable because it is easy.

In addition, a taper portion 3d in a direction in which the radius of the plug 3 decreases toward the tube 2 contact side of the elastomer plug 3 is provided so that the elastomer plug 3 is inserted into the tube 2. Is preferred from the standpoint of facilitating.

(Sealing Material) The sealing material 4 covering the upper surface of the elastomeric plug 3 can be stably held on the elastomeric plug 3 and is relatively easily peeled off from the elastomeric plug 3 when the sampling instrument is used. The material of the sealing material 4 is not particularly limited as long as it is possible. More specifically, as the material, known sheet materials such as paper and plastic film can be used. However, if contamination (β-glucan, etc.) derived from paper or its powder (chips, etc.) is a problem, use a material other than paper (plastic film, etc.) to form the sealant 4. Is preferred.

The sealing material 4 is usually adhered to the elastomer plug 3 using a suitable adhesive (for example, a commercially available acrylic adhesive, trade name: PA-T1, manufactured by Lintec Co., Ltd.). The type of the adhesive is not particularly limited as long as the sealing material 4 can be stably held on the elastomer stopper 3 and can be peeled off relatively easily from the elastomer stopper 3 when the collecting instrument is used. .

(Aseptic state) In the aseptic container or the aseptic collection instrument of the present invention, as long as the above-mentioned endotoxin-free state is realized, the manufacturing or sterilization means for realizing the state is particularly preferable. Not limited. When sterilization is performed after the device is manufactured, it is preferable to sterilize using radiation in terms of the balance between the sterilization effect and the ease of post-treatment. In the present specification, the term “radiation” is used to include electromagnetic waves and particle beams.

In the present invention, among the radiations, ionizing radiation having an ionizing action (ultraviolet rays having a short wavelength, X rays, γ rays, fast charged particle rays, fast neutron rays, etc.) is preferably used. Considering simplicity and transparency, it is preferable to use γ rays (gamma rays).

When sterilizing using γ-rays, the irradiation dose (kGy) is preferably about 10 kGy (1.0 Mrad; 1 Gy = 100 rad) or more, about 20 kGy or more, further 30 kGy or more, and particularly 30 to 50 kGy. It is preferable.

(Blood Coagulation Inhibitor) If necessary, a known blood coagulation inhibitor (for example, heparin, sodium citrate, sodium edetate (EDTA-Na)) is not coated inside the plastic tube 2. It may be contained.

(Usage Method) One mode of usage of the above-described sampling device 1 of the present invention will be described.

When the sampling device 1 of the present invention is used, it is usually used together with a sampling holder 5 as shown in the schematic sectional view of FIG. The sample-collecting holder 5 comprises a cylindrical member 5a into which the sample-collecting device 1 (FIG. 1) is to be inserted, and a needle 5b arranged on the bottom side of the cylindrical member 5a.

In using the sample collecting device 1 of the present invention, first, the needle 5b of the sample collecting holder 5 is inserted into an object to be sampled (for example, a vein of a human body), and then the sealing material 4 (FIG. 1). The sample collection tool 1 is inserted into the sample collection holder 5 from the side of the elastomer plug 3 from which the needle 5b is penetrated. When the sample-collecting device 1 is attached to the holder 5 in this manner, the sample (for example, blood) 6 to be collected is introduced into the plastic tube 2 based on the pressure reduction inside the plastic tube 2. (FIG. 2 (b)).

After the sample 6 is thus introduced into the plastic tube 2 of the sample collecting tool 1, the sample 6 can be easily collected by pulling out the sample collecting tool 1 from the holder 5. (Figure 3). The sample 6 thus collected using the collection device 1 of the present invention can be directly subjected to the next treatment (centrifugation treatment, cryopreservation treatment, etc.).

(Other Embodiments) Another preferred embodiment of the present invention is shown in FIG. In the embodiment shown in FIG. 4, the sealing material 4 has an upper layer 4b having a round planar shape with protrusions 4a and a donut-shaped planar shape arranged below the upper layer 4b (on the side of the elastomer plug 3). The lower layer 4c. With the configuration shown in FIG. 4, the degree of freedom in selecting the adhesive property between the seal material 4 and the elastomer plug 3 is increased. That is, since it is not necessary to peel off between the lower layer 4c and the elastomer plug 3, an adhesive that considers only the adhesive strength is used for bonding at this interface, while the adhesive at the interface between the upper layer 4b and the lower layer 4c is It is only necessary to use an adhesive that takes into consideration "some peelability" at this interface.

In the process of manufacturing the sampling device 1 of the present invention, when a lubricant or a mold release agent (silicone oil or the like) is used to smoothly insert the elastomeric plug 3 into the tube 2, the above-mentioned adhesive property is used. “Increasing the degree of freedom” in selection is particularly effective.

FIG. 5A is a schematic cross-sectional view showing another aspect of the sealing material 4 (FIG. 1). With reference to FIG. 5 (a), in this embodiment, the sealing material 14 having the protrusion 14 a (schematic plan view of FIG. 5 (b)) is used not only for the elastomer plug 3 but also for the outer wall of the plastic tube 2. It is also glued to. When the sealing material 14 is also adhered to the outer wall of the tube 2 as described above, the releasability (and / or the elastomer plug 3 of the elastomer material itself constituting the elastomer plug 3 is based on the adhesive force between the seal material / tube). The difficulty of adhesion between the elastomer stopper / sealing material based on the use of a mold release agent such as silicone oil when inserting into the tube 2 is alleviated. In other words, even if the adhesive force between the elastomer plug and the sealing material is relatively weak, the sealing material 14 will have its original function (contamination by the cover of the elastomeric plug 3) based on the adhesive force between the sealing material and the tube. Nation prevention) can be easily exerted.

In the embodiment of FIG. 5 (a), the sealing material 14 may be adhered to the elastomer plug 3 relatively weakly as long as the contamination can be prevented. It is also possible to omit the adhesion to 3.

(“Cut portion” of sealing material) When the sealing material 14 (adhered to the outer wall of the tube 2) of the embodiment of FIG. 5 described above is made of a plastic film (for example, PET film), the sampling device 1 From the viewpoint of easy removal of the sealing material 14 at the time of use, as shown in the schematic perspective view of FIG. 6A, the sealing material 14 has a “cutout portion” for facilitating the cutting of a part thereof. It is preferable that (14b and / or 14c) is contained. The shape and the like of the “cutout portion” (“perforation” in the embodiment of FIG. 6A) are not particularly limited as long as they have a function of facilitating the cutout of a part of the sealing material 14. For example, a “cutout” may be formed by making a “cut” in the sealing material 14 from one side or both sides to partially reduce the width of the sealing material 14.

When the sample-collecting device 1 of the embodiment shown in FIG. 6A is used to collect an actual sample (blood or the like), first, as shown in the schematic perspective view of FIG. At times, a sample is taken by cutting only the upper portion 14d of the sealing material 14 along the first perforation 14b and peeling it off from the elastomer plug 3 (FIG. 2 (b)). Thereafter, when the collected sample is subjected to various inspections (endotoxin inspection, etc.), the remaining portion of the sealing material 14 is cut along the second perforation 14c as shown in FIG. 7 (c). Good.

FIGS. 6B to 6C show other modes of perforations. The first perforation 14b is sufficient if it is in a position that allows the needle 5b to be inserted into the elastomer stopper 3 when a sample is taken (FIG. 2 (b)). Therefore, as shown in FIGS. 6B to 6C, the first perforation 14b may be located on the upper side (rounded portion) of the elastomer plug 3. However, in order to suppress the possibility that "chips" based on the cutting operation along the perforations 14b and / or 14c may become a new contamination in various inspections, the first perforation 14b is As shown in FIG. 6 (a) and the like, it is preferable to provide it on the side close to the side surface 3c of the elastomer stopper 3.

In the sealing material 14 having the perforations 14b and / or 14c shown in FIG. 6A, a wide portion 14e is further provided on the side closer to the tube 2 than the second perforations 14c. It is preferable from the viewpoint of increasing the adhesive force between the sealing material and the tube, and from the point of facilitating the addition of letters, symbols, etc. for identification or attention to the sealing material 14 (wide portion 14e) (FIG. 8).

As shown in the schematic perspective view of FIG. 9A, the sealing material 14 may be in a double seal mode. In this case, two or more "adhesive feet" (or wide parts) are attached to the tube 2.

FIG. 9 (b) shows an unused state of the sampling instrument of such a mode, and FIG. 9 (c) shows a state immediately before being used for sample collection.

(Cap) In the present invention, as shown in the schematic perspective view of FIG. 10A, a cap made of plastic such as polyethylene (cup-shaped; inside is provided between the seal member 14 and the elastomer stopper 3). You may arrange | position the recessed part (which has a recessed part (not shown)) 15 which fits the outer periphery of the elastomer stopper 3. When the cap 15 is arranged in this way, the prevention of contamination of the elastomer plug 3 is increased due to the improved adhesion between the cap 15 and the elastomer plug 3, and as shown in FIG. 10 (c). In addition, it becomes easy to cut the sealing material 14 along the perforations 14b. Furthermore, it becomes easy to select an adhesive agent that should adhere between the sealing material 14 and the cap 15.

FIG. 10 (b) shows an unused state of the sampling instrument of such a mode, and FIG. 10 (c) shows a state immediately before being used for sampling.

(Prevention of Contamination by Bag-shaped Member) In the above-mentioned embodiment, the upper portion of the elastomeric plug 3 is covered with the sealing material 4 or 14 to prevent contamination due to falling bacteria, etc. As long as the prevention is possible, the plastic tube 2 and the elastomer plug 3 may be sealed in the bag-shaped member 16 as shown in the schematic view of FIG. 11. In the embodiment shown in FIG. 11, the sealing material 4 or 14 (FIGS. 1 and 5) for covering the elastomeric plug 3 is unnecessary.

The bag-like member 16 in such an embodiment can be made of the same plastic or laminate as the tube 2, but from the viewpoint of flexibility, it is made of a polyolefin resin such as PE or PP. Is preferred.

From the viewpoints of flexibility and predetermined strength (difficult to break during storage before use), the film constituting the bag-shaped member 1 has a thickness of about 20 to 200 μm, further 30 to 100 μm. Preferably there is.

The bag-shaped member 16 may be sealed with the sealing portion 16a at least at one position by an adhesive, heating (for example, conduction heating, dielectric heating, ultrasonic heating) or the like. In addition, the materials of the sheets forming the front and back of the bag-shaped member 16 may be different (for example, one of the sheets may be made of an opaque material such as synthetic paper).

In a mode in which the bag-shaped member 16 is used, when sterilization is performed after the sample-collecting device 1 is manufactured, the sampling device 1 is sealed in the bag-shaped member 16 and sterilized by using radiation or the like. do it.

[0058]

[Effect of device]

 As described above, according to the present invention, a bottomed plastic tube whose inside is endotoxin-free and whose inside is in a depressurized state; and which substantially holds the depressurized state inside the plastic tube Thus, there is provided an aseptic sampling device comprising an elastomer stopper arranged on the opening side of the tube and a sealant covering at least a part of the upper portion of the elastomer stopper.

By using the sampling instrument of the present invention, a simple aseptic sample can be collected without impairing the integrity of the aseptic operation.

[Brief description of drawings]

FIG. 1 is a schematic side view showing an embodiment of a sampling device of the present invention.

FIG. 2 is a schematic cross-sectional view showing one aspect of using the sampling instrument of the present invention together with a sampling holder.

FIG. 3 is a schematic cross-sectional view showing an example of a state after a sample is collected by using the sampling device of the present invention.

FIG. 4 is a schematic view showing an embodiment of a sampling device of the present invention in which the sealing material has a double seal structure.

FIG. 5 is a schematic view showing an embodiment of a sampling device of the present invention in which a sealing material is adhered to an outer wall of a plastic tube.

FIG. 6 is a schematic plan view showing another embodiment of the sealing material that can be used in the sampling device of the present invention.

FIG. 7 is a schematic perspective view showing an embodiment of a sampling instrument of the present invention using a perforated sealing material and a method of using the same.

FIG. 8 is a schematic plan view showing one embodiment of a sealing material in which a “wide portion” is provided below a second perforation.

FIG. 9 is a schematic perspective view showing an embodiment of a sampling instrument of the present invention using a seal material having a double seal structure and a method of using the same.

FIG. 10 is a schematic perspective view showing an embodiment of the sampling device of the present invention in which a cap member is further arranged between the sealing material and the plastic tube, and a method of using the sampling device.

FIG. 11 is a schematic view showing an embodiment of a sampling device of the present invention in which a bag-shaped member is used in place of the sealing material to prevent contamination.

FIG. 12 is a schematic perspective view showing a method of using the aseptic sampling device according to the prior application of the present inventor.

[Explanation of symbols]

1 ... Aseptic sampling device, 2 ... Plastic tube,
3 ... Elastomer stopper, 4 ... Sealing material, 5 ... Sampling holder, 6 ... Sampling sample, 14 ... Sealing material, 14b, 1
4c ... Perforation, 14e ... Wide part.

Claims (14)

[Scope of utility model registration request] 1. A bottomed plastic tube whose inside is aseptic to the extent that endotoxin is substantially absent and whose inside is depressurized to the extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. An aseptic sampling device comprising a sealing material adhered to the elastomer stopper so as to cover it. 2. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sterilized sample comprising a sealing material adhered to the elastomer stopper so as to cover it, and a sealing material comprising a lower layer adhered to the elastomer stopper and an upper layer adhered to the lower layer. Collection tool. 3. A bottomed plastic tube whose inside is aseptic to the extent that endotoxin is substantially absent and whose inside is in a reduced pressure state so that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sterile sample-collecting device, comprising: a sealing material, which is adhered to the elastomer plug so as to cover it, and a part thereof is also adhered to the outer wall of the plastic tube. 4. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sealing material adhered to the elastomer plug so as to cover it, comprising a lower layer adhered to the elastomer plug and an upper layer adhered to the lower layer, and the lower layer on the outer wall of the plastic tube. An aseptic sampling device, comprising: a sealing material having a part thereof bonded. 5. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and whose interior is depressurized to the extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sealing material adhered to the elastomer plug so as to cover it, a part of which is adhered to the outer wall of the plastic tube, and a "cutout part" at a part other than the adhesive part to the elastomer plug. A sterile sample-collecting device, comprising: 6. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sealing material adhered to the elastomer plug so as to cover it, a part of which is adhered to the outer wall of the plastic tube, and a "cutout part" at a part other than the adhesive part to the elastomer plug. An aseptic sampling device comprising: a sealing material provided with; a first cutting part to be cut at the time of sampling , Sterile sampling instrument, characterized in that comprising a second cut portion to be cut at the time of inspection of the collected samples. 7. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sealing material adhered to the elastomer plug so as to cover it, a part of which is adhered to the outer wall of the plastic tube, and a "cutout part" at a part other than the adhesive part to the elastomer plug. An aseptic sampling device comprising: a sealing material provided with; a first cutting part to be cut at the time of sampling And a second cutout to be cut when the sample is inspected; and the first cutout is located at a position corresponding to a side surface of the elastomeric stopper. . 8. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, At least a part of an elastomer stopper disposed on the opening side of the plastic tube and a surface of the elastomer stopper opposite to the plastic tube contact side so as to substantially maintain the reduced pressure inside the plastic tube. A sealing material which is adhered to the elastomer stopper so as to cover it and a part of which is also adhered to the outer wall of the plastic tube; a "cutout" is provided in a portion other than the adhesive portion to the elastomer stopper. An aseptic sampling device comprising: a sealing material; and a first cutting part to be cut during sampling. It consists of a the second cut portion to be cut at the time of inspection of the sample; first
Has a cutout portion corresponding to a side surface portion of the elastomer stopper; and a wide portion is provided on the side closer to the position where the sealing material is closer to the plastic tube than the adhesive portion to the elastomer stopper. An aseptic sampling device characterized by having. 9. A bottomed plastic tube whose inside is sterile to the extent that endotoxin is substantially absent and whose inside is depressurized to the extent that a biological sample can be collected, An elastomer stopper disposed on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube, and the elastomer so as to cover the surface of the elastomer stopper opposite to the plastic tube contact side. The cap member disposed on the stopper is adhered to the cap member so as to cover at least a part of the surface of the cap member opposite to the elastomer stopper contact side, and the plastic tube outer wall also has one of them. An aseptic sampling device, comprising: a sealing material having a bonded portion. A 10. A substantially its interior aseptically to the extent that endotoxin is not present, and the plastic tubing with a bottom ing its internal as vacuum state to an extent capable of collecting the biological sample, An elastomer stopper disposed on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube, and the elastomer stopper covering the surface of the elastomer stopper opposite to the plastic tube contact side. A cap member disposed on the elastomeric plug, adhered to the cap member so as to cover at least a part of a surface of the cap member opposite to the elastomeric plug contact side, and also on the outer wall of the plastic tube; A sealing material partially adhered; and a seal member provided with a "cutout" at a portion other than the portion adhered to the elastomer stopper. Sterile sampling device characterized by comprising: 11. substantially its interior aseptically to the extent that endotoxin is not present, and the plastic tubing with a bottom ing its internal as vacuum state to an extent capable of collecting the biological sample, An elastomer stopper disposed on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube, and the elastomer stopper covering the surface of the elastomer stopper opposite to the plastic tube contact side. A cap member disposed on the elastomeric plug and adhered to the cap member so as to cover at least a part of a surface of the cap member opposite to the elastomeric plug contact side, and a part thereof also on the outer wall of the plastic tube. A sealing material obtained by adhering; and a sealing material provided with a "cutout" at a portion other than the portion to be adhered to the elastomer plug. A sterile sampling device comprising:
The cutout is a first cut to be cut at the time of sampling.
An aseptic sample collecting instrument, comprising: a cut-out part and a second cut-out part to be cut at the time of inspection of the collected sample. A 12. A substantially its interior aseptically to the extent that endotoxin is not present, and the plastic tubing with a bottom ing its internal as vacuum state to an extent capable of collecting the biological sample, An elastomer stopper disposed on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube, and the elastomer stopper covering the surface of the elastomer stopper opposite to the plastic tube contact side. A cap member disposed on the elastomeric plug, adhered to the cap member so as to cover at least a part of a surface of the cap member opposite to the elastomeric plug contact side, and also on the outer wall of the plastic tube; A sealing material partially adhered; and a seal member provided with a "cutout" at a portion other than the portion adhered to the elastomer stopper. And a second cutout part to be cut at the time of inspection of the collected sample. And the first
The aseptic sampling device is characterized in that the cut-out portion of is at a position corresponding to the side surface portion of the elastomer stopper. 13. A bottomed plastic tube which is aseptic to the extent that endotoxin is substantially absent and which is depressurized to such an extent that a biological sample can be collected, An aseptic method characterized in that a plastic tube is sealed with an elastomer stopper arranged on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube. Sampling instrument. 14. substantially its interior aseptically to the extent that endotoxin is not present, and the plastic tubing with a bottom ing its internal as vacuum state to an extent capable of collecting the biological sample, An elastomer stopper disposed on the opening side of the plastic tube so as to substantially maintain the reduced pressure inside the plastic tube, and the elastomer stopper covering the surface of the elastomer stopper opposite to the plastic tube contact side. A cap member disposed on the elastomeric plug and adhered to the cap member so as to cover at least a part of a surface of the cap member opposite to the elastomeric plug contact side, and a part thereof also on the outer wall of the plastic tube. A sealing material obtained by adhering; and a sealing material provided with a "cutout" at a portion other than the portion to be adhered to the elastomer plug. A sterile sampling device comprising:
The cutout is a first cut to be cut at the time of sampling.
And a second cutout to be cut when inspecting the collected sample; the first cutout is at a position corresponding to the side surface of the elastomer plug; and the sealing material. However, the aseptic sampling device is characterized in that it has a wide portion on the side closer to the adhesive portion to the plastic tube than the adhesive portion to the elastomer stopper.